The FDA issued a notice today labeling the recall of GE Healthcare’s (NYSE:GE) Carescape R860 ventilator as Class I, the most serious kind.
GE Healthcare recalled the Carescape R860 ventilator backup batteries, including replacement backup batteries, because the batteries may run out before they are expected to do so. If the ventilator is running on batter power only when the battery fails, the ventilation could stop completely, preventing the user from receiving oxygen and breathing support.
Carescape R860 uses main AC power via a wall plug to operate, but has a backup battery intended to keep the ventilator operating for a certain amount of time if a main AC power supply is not available. An example of this occurrence would be a patient transport. Replacement backup batteries are available for use when the original backup battery expires.
The issue can potentially cause a lack of oxygen (hypoxia), especially if it occurs over a long period, which can cause serious injury and death. There have been 1,553 complaints, one injury and zero deaths associated with the use of the device.
According to the FDA notice, the recall affected 4,222 devices in the U.S., all of which were distributed between April 2, 2019, and April 18, 2022. The company initiated the recall on April 18, 2022.
GE Healthcare issued an urgent medical device correction letter to customers on that day, recommending that users perform a battery performance test immediately after receiving the correction letter, every three months and before using if the device has been in storage for more than three months.
Users were also instructed to continue to use the affected ventilators while the ventilator is connected to an AC mains power source supported by backup emergency power. If use of the ventilator by battery power is necessary, such as during transport where alternative options are limited, users should follow standard clinical practice when it comes to administering the appropriately readily accessible alternative ventilation, such as a bag-valve system.
Batteries should be replaced when necessary before patient use and the ventilator should remain connected to the AC main power source when not in use, even in storage, to prevent battery discharge and degradation. Backup batteries should be replaced at a minimum of every three years.